CICATRIN

Main information

  • Trade name:
  • CICATRIN Cutaneous Powder
  • Pharmaceutical form:
  • Cutaneous Powder
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CICATRIN Cutaneous Powder
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1077/054/002
  • Authorization date:
  • 01-04-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CicatrinCutaneousPowder.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachgramofpowdercontains:

NeomycinSulphate 3,300units

BacitracinZinc 250units

Glycine 10mg

L(+)Cysteine 2mg

DL-Threonine 1mg

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cutaneouspowder.

Acreamtowhitefree-flowingpowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

CicatrinPowderisbroad-spectrumbactericidalpreparationsactiveagainstpathogenscommonlyfoundininfectionsof

theskin.Theyareindicatedinthepreventionortreatmentofsuperficialskininfection.Theseinclude:-

Prophylaxisinminorburns,cuts,scratchesandabrasionsandfollowingthesuturingoflacerations.

Treatmentofsuperficialinfectedulcers,cuts,scratches,andabrasions,superficialskininfectionsfollowingsurgical

procedures,minorburns,impetigoandsecondarilyinfectedskinconditions.

TheuseofCicatrinPowderdoesnotexcludeconcomitantsystemictherapywithotherantibioticswhereappropriate.

(SeeSpecialWarningsandSpecialPrecautionsforUse).

4.2Posologyandmethodofadministration

(Prophylaxisandtreatment).

Administrationanddosageinadults:

Beforeuse,theareaforapplicationshouldbecleanedgently.Debrissuchaspusorcrustsshouldberemovedfromthe

affectedarea.

Alightdustingofpowdershouldbeappliedoncetofourtimesdaily,dependingontheclinicalcondition.Treatment

shouldnotbecontinuedformorethan7dayswithoutmedicalsupervision(seeSpecialWarningsandSpecial

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Dosageinchildren:

CicatrinPowderissuitableforuseinchildren(2yearsandover)atthesamedoseasadults.Apossibilityofincreased

absorptionexistsinveryyoungchildren,thusCicatrinPowderisnotrecommendedforuseinneonatesandinfants(<2

years)(see4.3Contra-Indicationsand4.4SpecialWarningsandSpecialPrecautionsforUse).

Dosageintheelderly:

CicatrinPowderissuitableforuseintheelderly.Cautionshouldbeexercisedincaseswhereadecreaseinrenal

functionexistsandsignificantsystemicabsorptionofneomycinsulphatemayoccur(see4.2DosageinRenal

Impairmentand4.4SpecialWarningsandSpecialPrecautionsforUse).

Dosageinpatientswithrenalimpairment:

Dosageshouldbereducedinpatientswithreducedrenalfunction(seeSpecialWarningsandSpecialPrecautionsfor

Use).

4.3Contraindications

TheuseofCicatrinPowderiscontra-indicatedinpatientswhohavedemonstratedallergichypersensitivitytoany

componentofthepreparationortocross-sensitisingsubstancessuchasframycetin,kanamycin,gentamycinandother

relatedantibiotics.

TheuseofCicatrinPowderiscontra-indicatedinpatientshypersensitivetopolymyxinBorneomycin.

Thepresenceofpre-existingnervedeafnessisacontra-indicationtotheuseofCicatrinPowderoranytopical

aminoglycosideincircumstanceswheresignificantsystemicabsorptioncouldoccur.

TheuseofCicatrinPowderduringpregnancyandlactationcannotberecommendedincircumstanceswheresignificant

systemicabsorptionoftheactiveingredientsmayoccur(e.g.applicationtolargeareasofrawskin).

Duetotheknownototoxicandnephrotoxicpotentialofneomycinsulphate,theuseofCicatrinPowderinlarge

quantitiesoronlargeareasforprolongedperiodsoftimeisnotrecommendedincircumstanceswheresignificant

systemicabsorptionmayoccur.

Apossibilityofincreasedabsorptionexistsinveryyoungchildren,thereforeCicatrinPowderisnotrecommendedfor

useinneonatesandinfants(upto2years).Inneonatesandinfants,absorptionbyimmatureskinmaybeenhanced,and

renalfunctionmaybeimmature.

CicatrinPowdershouldnotbeappliedtotheeyes.

4.4Specialwarningsandprecautionsforuse

Cautionshouldbeexercisedsothattherecommendeddosageisnotexceeded(seePosologyandMethodof

AdministrationandContraindications).

Followingsignificantsystemicabsorption,aminoglycosidessuchasneomycincancauseirreversibleototoxicityand

bothneomycinsulphateandbacitracinzinchavenephrotoxicpotential.

Inrenalimpairmenttheplasmaclearanceofneomycinisreduced(seeDosageinrenalimpairment).

Aswithotherantibacterialpreparations,prolongedusemayresultinovergrowthbynonsusceptibleorganisms,

includingfungi.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Followingsignificantsystemicabsorptionneomycinsulphatecanintensifyandprolongtherespiratorydepressant

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4.6Pregnancyandlactation

Teratogenicity:

Thereisinsufficientinformationavailabletodeterminewhethertheactiveingredientshaveteratogenicpotential.

Neomycinpresentinmaternalbloodcancrosstheplacentaandmaygiverisetoatheoreticalriskoffoetalototoxicity.

Fertility:

Thereisinsufficientinformationavailabletodeterminewhetheranyoftheactiveingredientscanaffectfertility.

Pregnancy:

Thereislittleinformationtodemonstratethepossibleeffectoftopicallyappliedneomycininpregnancyandlactation,

thereforeuseofCicatrinPowderisnotrecommended.

Lactation:

Noinformationisavailableregardingtheexcretionoftheactiveingredientinhumanmilk.

4.7Effectsonabilitytodriveandusemachines

Notrelevant.

4.8Undesirableeffects

Theincidenceofallergichypersensitivitytoneomycinsulphateinthegeneralpopulationislow.However,thereisan

increasedincidenceofsensitivitytoneomycinincertainselectedgroupsofpatientsindermatologicalpractice,

particularlythosewithvenousstasiseczemaandulceration.

Allergichypersensitivitytoneomycinfollowingtopicalapplicationmaymanifestitselfasareddeningandscalingof

theaffectedskin,asaneczematousexacerbationofthelesion,orasafailureofthelesiontoheal.

Allergichypersensitivityfollowingtopicalapplicationofbacitracinzinchasbeenreportedbutrare.

Anaphylacticreactionsfollowingthetopicaladministrationofbacitracinzinchavebeenreportedbutarerare.

4.9Overdose

Symptomsandsigns:

NospecificacutesymptomsorsignshavebeenidentifiedinassociationwithexcessiveuseofCicatrinPowder.

However,considerationshouldbegiventosignificantsystemicabsorption(seesection4.4,SpecialWarningsand

SpecialPrecautionsforUse).

Management:

Useoftheproductshouldbestoppedandthepatient’sgeneralstatus,hearingacuity,renalandneuromuscular

functionsshouldbemonitored.

Bloodlevelsofneomycinsulphateandbacitracinzincshouldalsobedeterminedandhaemodialysismayreducethe

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Nodata.

5.2Pharmacokineticproperties

Nodata.

5.3Preclinicalsafetydata

Mutagenicity:

Thereisinsufficientinformationavailabletodeterminewhethertheactiveingredientshavemutagenicpotential.

Carinogenicity:

Thereisinsufficientinformationavailabletodeterminewhethertheactiveingredientshavecarcinogenicpotential.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Maizestarch

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Keepthecontainertightlyclosed.

6.5Natureandcontentsofcontainer

Apolythenebottlewithnozzlecontaining15gor50gofacreamtowhitefree-flowingpowder.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

CicatrinPowdershouldnotbediluted.

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKline(Ireland)Limited

StonemasonsWay

Rathfarnham

Irish Medicines Board

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8MARKETINGAUTHORISATIONNUMBER

PA1077/054/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1977

Dateoflastrenewal:01April2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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